Bio-Rad Laboratories, a provider of life science research and clinical diagnostic products, launched its first ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. 

The assay expands the company’s droplet digital PCR (ddPCR) offering for the oncology market, where highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring, the company says.

Improved Sensitivity: Key Features of ddPLEX ESR1 Mutation Detection Kit

The ddPLEX ESR1 Mutation Detection Kit enables simultaneous detection, discrimination, and absolute quantification of seven known relevant ESR1 mutations, in a single well, with an analytical sensitivity down to 0.01% variant allele fraction (VAF).

The kit includes controls and enables same-day results from either circulating tumor DNA (ctDNA) from plasma or DNA from formalin-fixed paraffin-embedded (FFPE) tissue samples. This research use assay is developed for Bio-Rad’s QX600 Droplet Digital PCR System, which brings advanced multiplexing and sensitivity to a simple workflow with powerful data analysis. The assay is the first to license NuProbe’s allele enrichment technology, in a collaboration the two companies announced in 2022. 

“With the ddPLEX ESR1 Mutation Detection Kit, our customers can achieve new levels of sensitivity and multiplexing without compromising throughput,” says Stephen Kulisch, vice president of marketing for Bio-Rad’s Digital Biology Group. “This launch reflects our ongoing menu expansion in oncology and our commitment to providing oncology researchers with technologies that enable everything from biomarker discovery to clinical trials that support improvements in patient monitoring.” 

Further reading: Bio-Rad Launches Test Kits for Replication Competent Viruses 

Bio-Rad provides complete solutions in digital PCR to the research and diagnostics communities, including instrumentation, software, reagents, and the most expansive menu of digital PCR assays on the market for applications spanning translational research, cell and gene therapy, and environmental monitoring. Droplet Digital PCR has been cited in over 8,300 publications, including more than 800 clinical research citations.

Further reading: Why ESR1 Mutation Monitoring Can Keep One Step Ahead of Breast Cancer

Featured image: ddPLEX ESR1 Mutation Detection Kit. Photo: Bio-Rad Labs